Denison Pharmaceuticals, LLC

Complete recall history across all FDA and CPSC categories — 8 total recalls

Denison Pharmaceuticals, LLC appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Drug Recalls (8)

FDA drug safety enforcement actions by Denison Pharmaceuticals, LLC

Date Product Reason Class
Feb 24, 2025 Zapzyt, Acne Treatment Gel, 10% benzoyl peroxide Gel, packaged in 1 oz (28.35... Chemical Contamination: Presence of benzene. Class II
Sep 25, 2024 Kids' Cough and Chest Congestion (Dextromethorphan HBr, USP 5mg/ Guaifenesin,... Crystallization: Lack of uniformity - a change in texture, chunky, grainy, an... Class III
Sep 25, 2024 Adult Cough and Chest Congestion (Dextromethorphan HBr USP 20 mg, Guaifenesin... Crystallization: Lack of uniformity - a change in texture, chunky, grainy, an... Class III
May 28, 2024 Little Remedies Gas Relief Drops (Simethicone/Antigas), packaged in 1 fl. oz.... cGMP deviations: Test results confirmed aypical Burkholderia Cepacia were a r... Class II
May 3, 2023 Safe tussin DM, DAY TIME Cough Relief, (Dextromethorphan HBr, USP 10mg Guaife... CGMP Deviations: Use of non-food grade lubricant in mixing vessel. Class II
May 3, 2023 Colic Calm, Colic, Gas & Reflux, Homeopathic Medicine, 2 Fl. Oz (59 ml) bottl... CGMP Deviations: Use of non-food grade lubricant in mixing vessel. Class II
May 3, 2023 Safe tussin PM, NIGHT TIME Cough Relief, (Dextromethorphan HBr, USP 7.5mg, Do... CGMP Deviations: Use of non-food grade lubricant in mixing vessel. Class II
May 3, 2023 Pin-Away PYRENTAL PAMOATE (Pyrantel base 50 mg / mL) Pinworm Treatment, 2 FL ... CGMP Deviations: Use of non-food grade lubricant in mixing vessel. Class II

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

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